# 42 CFR § 11.22: Which applicable clinical trials must be registered?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-42-11.22

## Section

- **Citation:** 42 CFR § 11.22
- **Heading:** Which applicable clinical trials must be registered?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 42—Public Health > CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL PROVISIONS > PART 11—CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION > Subpart B—Registration

## Text

(a) General specification. (1) Any applicable clinical trial that is initiated after September 27, 2007, must be registered.
(2) Any applicable clinical trial that is initiated on or before September 27, 2007, and is ongoing on December 26, 2007, must be registered.
(3) Determining the date of initiation for an applicable clinical trial. An applicable clinical trial, other than a pediatric postmarket surveillance of a device product that is not a clinical trial, is considered to be initiated on the date on which the first human subject is enrolled. A pediatric postmarket surveillance of a device product that is not a clinical trial is considered to be initiated on the date on which FDA approves the plan for conducting the surveillance.
(b) Determination of applicable clinical trial for a clinical trial or study initiated on or after January 18, 2017. A clinical trial or study that, at any point in time, meets the conditions listed in paragraph (b)(1) or (2) of this section will be considered to meet the definition of an applicable clinical trial.
(1) Applicable device clinical trial. A clinical trial or study that meets the conditions listed in either paragraph (b)(1)(i) or (ii) of this section is an applicable device clinical trial:
(i) The study is a pediatric postmarket surveillance of a device product as required by FDA under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601).
(ii) The study is a clinical trial with one or more arms that meets all of the following criteria:
(A) Study Type is interventional;
(B) Primary Purpose of the clinical trial is other than a feasibility study;
(C) The clinical trial Studies a U.S. FDA-regulated Device Product; and
(D) One or more of the following applies:
(1) At least one Facility Location is within the United States or one of its territories,
(2) A device product under investigation is a Product Manufactured in and Exported from the U.S. or one of its territories for study in another country, or
(3) The clinical trial has a U.S. Food and Drug Administration IDE Number.
(2) Applicable drug clinical trial. A clinical trial with one or more arms that meets the following conditions is an applicable drug clinical trial:
(i) Study Type is interventional;
(ii) Study Phase is other than phase 1;
(iii) The clinical trial Studies a U.S. FDA-regulated Drug Product; and
(iv) One or more of the following applies:
(A) At least one Facility Location for the clinical trial is within the United States or one of its territories,
(B) A drug product (including a biological product) under investigation is a Product Manufactured in and Exported from the U.S. or one of its territories for study in another country, or
(C) The clinical trial has a U.S. Food and Drug Administration IND Number.

## Nearby sections

- [42 CFR § 11.2 § 11.2 What is the purpose of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.2.md)
- [42 CFR § 11.4 § 11.4 To whom does this part apply?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.4.md)
- [42 CFR § 11.6 § 11.6 What are the requirements for the submission of truthful information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.6.md)
- [42 CFR § 11.8 § 11.8 In what format must clinical trial information be submitted?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.8.md)
- [42 CFR § 11.10 § 11.10 What definitions apply to this part?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.10.md)
- [42 CFR § 11.20 § 11.20 Who must submit clinical trial registration information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.20.md)
- [42 CFR § 11.22 § 11.22 Which applicable clinical trials must be registered?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.22.md)
- [42 CFR § 11.24 § 11.24 When must clinical trial registration information be submitted?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.24.md)
- [42 CFR § 11.28 § 11.28 What constitutes clinical trial registration information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.28.md)
- [42 CFR § 11.35 § 11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.35.md)
- [42 CFR § 11.40 § 11.40 Who must submit clinical trial results information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.40.md)
- [42 CFR § 11.42 § 11.42 For which applicable clinical trials must clinical trial results information be submitted?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.42.md)
- [42 CFR § 11.44 § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.44.md)
- [42 CFR § 11.48 § 11.48 What constitutes clinical trial results information?](https://www.frixlaw.com/law-library/statutes/ecfr-42-11.48.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-42-11.22. Check the current official text before relying on it. Not legal advice.